(15 days)
Light Sources LS-1800XG (Med Light X180), LS-3000X, LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.
The Endoscopic Light Source LS-300X uses a 300W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 5600°K and the lamp life is approximately 500 hours.
The Endoscopic Light Source LS-1800X (Med Light X 180) uses a 180W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 6000°K and the lamp life is approximately 500 hours.
The Endoscopic Light Source LS-2500H (Med Light H 250) uses two 250W halogen lamps to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 3400°K and the lamp life is approximately 50 hours.
The provided text describes a 510(k) premarket notification for an Endoscopic Light Source. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set ground truth cannot be fully extracted from the provided text because it primarily addresses regulatory compliance through substantial equivalence.
Here's why and what information can be gathered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, or image quality scores. Instead, the "acceptance criteria" are implied by the requirement to be "substantially equivalent" to predicate devices. This means the device must perform similarly to widely accepted and commercialized devices.
- Reported Device Performance: The primary "performance data" mentioned is compliance with several international and European standards, indicating safety and general functionality. No specific individual performance metrics are provided that would typically populate such a table for an AI/diagnostic device.
| Criteria (Implied) | Performance (Reported) |
|---|---|
| Substantial Equivalence to Predicate Devices (K021717, K023468, K20889) | "The new devices have no diminished safety or effectiveness." "The differences... are minor and raise no new questions of safety and effectiveness." |
| Compliance with IEC 60601-1 (General medical electrical equipment) | Will comply |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Will comply |
| Compliance with IEC 60601-2-18 (Endoscopic equipment) | Will comply |
| Conformance to Medical Device Directive 93/42/EEC | Will conform |
| Illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals | Intent of the device |
| Lamp Characteristics (W, color temp, life) | Listed for each model (e.g., LS-3000X: 300W Xenon, 5600°K, 500 hrs) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This is not a clinical study involving a "test set" of patient data. The evaluation is largely based on technical specifications and comparison to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. Ground truth for a diagnostic test is not relevant here as this is a medical device for illumination, not for diagnosis based on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This is an endoscopic light source, not a diagnostic AI tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware device, not an algorithm. Its "standalone" performance is its ability to produce light according to its specifications.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the context of a diagnostic test. The "truth" for this device lies in its technical specifications and compliance with safety and performance standards.
8. The sample size for the training set
- Not applicable/Not provided. This device is not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set is relevant.
Summary in relation to the provided document:
The provided document is a 510(k) summary, which aims to demonstrate that a new medical device is "substantially equivalent" to existing, legally marketed predicate devices. This regulatory pathway relies on comparing the new device's technological characteristics, intended use, and safety/effectiveness profile to the predicates, rather than conducting new clinical trials to establish novel performance metrics or compare it against a gold standard in a diagnostic context.
The "study" that proves the device meets the (implied) acceptance criteria of substantial equivalence is primarily a technical assessment and comparison to established predicate devices and compliance with relevant international and European standards for medical electrical equipment. No clinical studies involving patient data, expert readers, or AI algorithms were conducted or reported in this summary.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.